Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA)

This study has been completed.

Sponsor:

MEDA Pharma GmbH & Co. KG

ClinicalTrials.gov Identifier:

NCT00777127

First Posted: October 22, 2008

Last Update Posted: February 1, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period.

One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT.

Active Comparator: 2

Solaraze 3% Gel

Drug: Diclofenac

Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks.

Eligibility

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Immunocompetent patient.

A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.

A positive histological finding for AK grade I or II (see Section 7.1.1.2). This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.

Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.

Lack of suitability for the study:

Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns.

Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.

Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.

Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.

Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.

Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).

Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).

Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.

History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).

History of any malignant skin tumour having metastasised or where metastasis could be expected.

History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.

Mentally incapacitated patient.

Present or history of drug or alcohol abuse within the last 3 years.

Administrative reasons:

Exposure to an investigational product within the last 3 months.

Lack of ability or willingness to give informed consent.

Age below 18 years.

Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.

Anticipated non-availability for study visits/procedures.

Vulnerable subjects (such as persons kept in detention).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777127

Locations

Austria

Hospital Feldkirch, Department for Dermatology and Venereology

Feldkirch, Austria, A-6807

Medical University Graz, University Clinic for Dermatology and Venereology

Graz, Austria, A-8036

Medical University Innsbruck, University Clinic for Dermatology and Venereology